Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01281332
Eligibility Criteria:
Inclusion Criteria:
* Age range: 40 to 65 years
* Healthy postmenopausal woman
* natural or surgical menopause
* FSH \> 30 IU/L
* Amenorrhea \> 6 months prior to study
* Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase
Exclusion Criteria:
* Any therapy for hot flashes prior to or during study
* Obesity: BMI \> 35
* Alcohol abuse
* Drug abuse
* Unable to use device as per protocol
* Unable to complete required documentation
* Serious medical condition:
* coronary heart disease
* stroke
* chronic renal or hepatic disease
* diabetes
* depression or other psychiatric illness
* cancer
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01281332
Study Brief:
Protocol Section:
NCT01281332